RWD SIG

Purpose

To increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

Objectives

Our objectives include:

  • Facilitate sharing of case studies and experiences in this area
  • Collate and summarise publications, articles, presentations, training
  • Identify emerging news and trends
  • Organise and/or participate in workshops related to RWD
  • Collaborate with key stakeholder groups (EFSPI/PSI, EFPIA, ISPOR,  regulatory and academia)
  • Provide comments on RWD related guidelines, e.g. country-specific methods guidelines, FDA methods guidelines, ISPOR etc.
  • Develop/highlight best practices and recommendations
  • Influence industry practice and acceptance of approaches by regulators and other stakeholders

 

Let's T@lk Real Corner

This corner is created to discuss Real World Data (RWD) topics coming from industry, academia and Health Authorities.

Blog Posts:

Let's T@lk Real 19th December 2022

 

Who we are

NameCompany/Institution
Anny Stari (Co-chair)

GSK

Josephine Wolfram (Co-chair)Astellas
Peter Almgren

LEO Pharma

Anders Berglund 

Daiichi-Sankyo

Tobias Bluhmki 

Bristol Myers Squibb
Miranda Cooper BresMed 
Imi FaghmousKite Gilead
Fiona GrimsonUCB
Randi GrønNovo Nordisk

Alessandro Guasconi 

Chiesi Farmaceutici S.p.A.
Min-Hua JenEli Lilly
Daniel Leibovitz Incyte

Susan Lovick

Plus-Project
Elizabeth MerrallJanssen
Deepak Parashar  

Warwick University

Eleanor RalphsIQVIA
Antonio Remiro-Azocar Bayer
Alexander Schacht Veramed
Claire SmithAstraZeneca
Aijing ShangUCB

Toshifumi Sugitani

BMS
Rachel Tham Veramed
Barbara TorlinskaVisible Analytics Ltd. / University of Birmingham

Sudhir Venkatesan

AstraZeneca

Stefano Viaggi

ICON
Huajun WangGSK

Jixian Wang

Bristol Myers Squibb

Qing Wang 

Roche

Call for members

If you are interesting in joining the RWD SIG please contact Anny Stari or Josie Wolfram.

Frequency of Meetings

Bi-monthly teleconferences

 

Upcoming Events

PSI VisSIG Wonderful Wednesday Webinar Series (2023)

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Pre-Clinical SIG Webinar: End-user Tool for Immunogenicity Cut-points Calculation

This webinar will discuss the development of an adaptable yet fully automated end-user tool that allows a harmonized and regulatory compliant calculation and evaluation of immunogenicity cut-points. This will be followed by Q&A.

PSI Book Club

Welcome to PSI's book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.

PSI EIWG Webinar: Proposing Estimands from Different Perspectives

The webinar will build on the concepts and case studies previously discussed. A case study in heart failure will be presented from the perspective of multiple stakeholders.

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